Kornimate/medical-research-clean huggingface dataset:
the impact of co-dispensing naloxone to patients prescribed chronic opioid therapy

Conditions: Overdose; Risk Behavior

Summary: in the setting of naloxone standing orders, this study will assess if co-dispensing naloxone with opioids to patients prescribed chronic opioid therapy changes opioid risk behaviors, increases naloxone uptake, and increases knowledge about overdose and naloxone.

this is a pragmatic, pharmacy-based, cluster randomized controlled trial of a naloxone co-dispensing program for adults prescribed chronic opioid therapy. pharmacies (target n=6) will be randomized to the order in which they are encouraged to implement a naloxone co-dispensing program for patients prescribed chronic opioid therapy. the intent of this program is to provide patients prescribed chronic opioid therapy naloxone for potential opioid overdose reversal under the terms of a standing order. participants prescribed chronic opioid therapy who use randomized pharmacies will be recruited to receive knowledge and risk surveys at baseline and over the follow-up. the primary outcome is opioid risk behaviors (target enrollment is 200 patients). secondary outcomes include knowledge about overdose and naloxone, substance use, and pain intensity. patients who use randomized pharmacies (anticipated n=550 patients) will also be followed in the electronic health record for secondary outcomes: naloxone dispensings, changes in opioid dose, aberrant urine toxicology results, and overdose events.

Eligibility criteria:
study population: * eligible pharmacies * patients prescribed chronic opioid therapy inclusion criteria for pharmacies: * stock naloxone for outpatient dispensing. * pharmacy leadership willing to provide naloxone under a co-dispensing protocol. * pharmacy leadership willing to be randomized to order of implementation. * have or can implement a naloxone standing order. exclusion criteria for pharmacies: • none inclusion criteria for patients: * prescribed chronic opioid therapy and meet criteria for the pharmacy co-dispensing protocol * receive medications at participating pharmacies * have a health plan which covers the formulation of naloxone available at the pharmacy they received their opioid prescriptions from. * (for surveys)18 years of age or greater exclusion criteria: • (for surveys) non-english speaking, hospice enrollment, do-not-resuscitate order

Keywords: opioids naloxone co-dispensing cluster randomized trial opioid antagonist
epirubicin in treating women who are undergoing surgery for stage i, stage ii, or stage iii breast cancer

Conditions: Breast Cancer

Summary: rationale: drugs used in chemotherapy, such as epirubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. giving epirubicin before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. purpose: this phase ii trial is studying how well epirubicin works in treating women who are undergoing surgery for stage i, stage ii, or stage iii breast cancer.

objectives: primary * determine the complete pathological and clinical response rate in women undergoing surgery for resectable stage i-iii breast cancer treated with neoadjuvant dose-intensified epirubicin hydrochloride. secondary * determine the toxicity of this regimen in these patients. * determine the predictive value of her2 gene amplification and topoisomerase ii-alpha gene amplification or deletion for disease progression and pathological and clinical complete response in patients treated with this regimen. * correlate gene expression profiles with pathologic complete response, clinical complete response, less than complete response, and disease progression in patients treated with this regimen. outline: patients receive epirubicin hydrochloride iv on day 1 and pegfilgrastim subcutaneously on day 2. treatment repeats every 14 days for 4 courses in the absence of disease progression or unacceptable toxicity. four weeks later, patients undergo partial mastectomy or simple mastectomy plus an axillary staging procedure. after completion of study treatment, patients are followed periodically. projected accrual: a total of 30 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically confirmed invasive breast cancer * stage i, ii, or iii disease (t1, t2, or t4; n0-2; m0) * resectable disease * unidimensionally measurable disease * primary tumor ≥ 2 cm * no known distant metastases * hormone receptor status: * not specified patient characteristics: sex * female menopausal status * not specified performance status * ecog 0-2 life expectancy * not specified hematopoietic * wbc ≥ 3,500/mm\^3 * hemoglobin ≥ 8 g/dl * platelet count ≥ 100,000/mm\^3 * no known untreated bleeding diathesis hepatic * ast ≤ 2 times upper limits of normal * bilirubin ≤ 1.5 mg/dl renal * creatinine ≤ 1.5 mg/dl or * creatinine clearance ≥ 60 ml/min cardiovascular * lvef ≥ 50% on echocardiogram, muga, or cardiac catheterization other * not pregnant or breastfeeding * fertile patients must use effective contraception * negative pregnancy test * no concurrent illness that would preclude study treatment * no known hypersensitivity to escherichia coli-derived proteins, pegfilgrastim, filgrastim (g-csf), or any other component of these products prior concurrent therapy: not specified

Keywords: stage ii breast cancer stage i breast cancer stage iiia breast cancer stage iiib breast cancer
evaluation of inflammation of the anterior segment by laser flashmeter in patients having undergone surgery of the posterior segment (vitrectomy or preindentation) during the first postoperative year. (flavic)

Conditions: Inflammation Eye

Summary: observational study, monocentric, prospective, descriptive and comparative (eye operated vs fellow eye).

after surgery by vitrectomy or preindentation, an anti-inflammatory treatment is conventionally prescribed for a duration of 1 month. however, frequently, during the post-operative control at one month, there may be signs of ocular inflammation or symptoms of discomfort justifying the prolongation of post-operative treatment. a 2012 study evaluated post-operative flare follow-up in 22 vitrectomized patients for retinal detachment, and showed a significantly higher flare 3 months after surgery, compared to the other eye and pre-surgery value. in this study, the investigators wish to study postoperative inflammation in patients operated for posterior segment ocular surgery (vitrectomy or preindentation) measured by laser flashmeter on a follow-up of one year.

Eligibility criteria:
inclusion criteria: * major patient, * operation of vitrectomy or preindentation in the ophthalmology department of rennes university hospital for one of the following reasons: * retinal detachment, rhegmatogenous or not * combined surgery * membrane peeling * macular hole * optically targeted vitrectomy (terson's syndrome, intravitreous haemorrhage) * covered by a health insurance system, * having received information on the protocol and not having expressed opposition to participating in the study exclusion criteria: * vitrectomy for endophthalmitis or posterior uveitis, * patient with vitreoretinal proliferation (grade b and c), * pregnant or nursing woman, * major patient subject to legal protection (safeguard of justice, guardianship, guardianship), person deprived of liberty.

Keywords: vitrectomy cryoindentation
pulmonary rehabilitation after minimal invasive surgery in lung cancer

Conditions: Lung Cancer; Surgery

Summary: morbidity in the post-operative phase of pulmonary surgery is characterised by impairment due to pain, dyspnoea and loss of exercise tolerance. we demonstrated previously that rehabilitation after thoracotomy is limited due to pain. since minimal invasive surgery is the new standard in lung cancer, resulting in a reduction of postoperative pain, we believe there are new possibilities for post-operative integrated multidisciplinary rehabilitation in lung cancer.


Eligibility criteria:
inclusion criteria: 1. patients undergoing elective, minimal invasive surgery with intention to cure. 2. age between 18 and 80 years. 3. ecog 0 - 2 post-surgery. exclusion criteria: 1. patients with chronic pain 2. previous pulmonary surgery 3. comorbidity limiting rehabilitation 1. rheumatoid arthritis 2. severe ischaemic heart disease or myocardial failure; ef ≤ 35 %. 3. muscle disease 4. fibromyalgia 5. neurologic disorders (parkinson disease, cva and lesions of the spinal cord) 6. psychiatric disorders
longterm effectiveness of artificial intelligence-assisted colonoscopy on adenoma recurrence

Conditions: Screening Colonscopy

Summary: we hypothesize that ai-assisted colonoscopy can reduce post-colonoscopy neoplasia incidence after 3 years, over standard colonoscopy. moreover, this protective effect may allow surveillance intervals to be lengthened, by modifying long-term outcome of high-risk subgroup.

between april 2021 and july 2022, our group completed a parallel-group, randomized controlled trial in hong kong. \[endoaid-train study; nct04838951\] 856 subjects undergoing colonoscopies were randomized 1:1 to receive colonoscopies with cade (endo-aid, olympus co., japan) or standard colonoscopies (control). our study proved that ai-assisted colonoscopies could increase the overall adr, especially small-to-medium size adenomas. it remains questionable whether the increased detection and removal of these non-advanced adenomas can be translated into any sustained long-term benefit. the impact of this ai-driven intensive surveillance on general population and healthcare system is also largely unknown. in this research project, we aim to assess the long-term effectiveness of ai-assisted colonoscopy on adenoma recurrence and pccrc prevention, by conducting a real-world, prospective study with longitudinal extension from a randomized trial.

Eligibility criteria:
inclusion criteria: subjects are eligible if: (i) they underwent randomization to receive colonoscopy with/without cade in endoaid-train study \[nct04838951\]; (ii) they are fit and willing to undergo surveillance colonoscopy at year 3; (iii) written informed consent obtained. exclusion criteria: subjects will be excluded from the study if they have any of the followings: (i) incomplete colonoscopy during index procedure; (ii) known residual colorectal neoplasia not removed (except hyperplastic polyps); (iii) underwent unscheduled interval colonoscopy before year 3; (iv) contraindications to surveillance colonoscopy at year 3; (v) advanced comorbid (american society of anesthesiologists grade 4 or above); (vi) history of crc, hereditary polyposis syndrome or inflammatory bowel disease; (vii) history of colectomy at any time point.
collaborative studies on the genetics of asthma (csga)

Conditions: Asthma; Lung Diseases

Summary: to conduct molecular genetic studies in human pedigrees in order to identify the major genes responsible for asthma.

background: asthma is a respiratory disease characterized by variable airways obstruction, airways inflammation and bronchial hyperresponsiveness (bhr). there are recent increases in asthma mortality and prevalence in the us, especially in african-americans. multiple studies suggest that both genetic and environmental factors are important in asthma susceptibility. the study was recommended by the pulmonary diseases advisory committee at its february 1991 meeting and given concept approval by the may 1991 national heart, lung, and blood advisory council. the request for applications was released in october 1992. design narrative: the csga was composed of five centers (johns hopkins university, university of chicago, university of maryland, university of minnesota, and a data coordinating center at wake forest). at each center, families were ascertained through two siblings with asthma. all family members were characterized with spirometry, bronchial responsiveness to methacholine or reversibility testing, skin-tests and questionnaire data. the initial genome screen was completed on the first 237 sib pairs from three racial groups (african-american, caucasian and hispanic), and genotyping on the remaining family members and families was completed before the study was renewed in 1997. therefore, the initial aim of the csga to map susceptibility regions was completed, with detection of several novel chromosomal regions, and replication of several regions previously linked to associated phenotypes. in order to determine the importance of these regions in asthma susceptibility and the impact of environmental rink factors, the investigators l) evaluated the evidence for linkage in the complete csga data using 2-point, multipoint and multilocus approaches for asthma and associated phenotypes (including bhr, total serum ige and skin test reactivity to standardized allergens); 2) performed fine mapping studies of regions using additional genetic markers to obtain a \< 2 cm map; 3) identified candidate genes and novel sequence variants; and 4) characterized a patient population with asthma to study identified variants with respect to asthma severity and bronchial inflammation. these studies allowed identification of asthma susceptibility genes and their variants, interactions with other genes and environmental risk factors, as well as provided insight for the development of improved treatment and ultimate prevention of asthma.

Eligibility criteria:
no eligibility criteria
an open label pharmacokinetic, safety and efficacy study of maraviroc in combination with background therapy for the treatment of hiv-1 infected, ccr5 -tropic children

Conditions: Human Immunodeficiency Virus

Summary: the primary purpose of this study is to determine the pharmacokinetic properties (what the body does to maraviroc) and to determine a suitable dosing schedule of maraviroc in hiv-1 infected children and adolescents. this study will also determine whether maraviroc is safe to use in children and adolescents.


Eligibility criteria:
inclusion criteria: * subjects who are 2-18 years of age, treatment experienced for 6 months or longer with at least 2 arv drug classes, with hiv-1 rna ≥1,000 copies/ml exclusion criteria: * x4- or dual/mixed-tropic virus detected by the trofile™ viral tropism assay * concomitant therapy with other investigational agents (other than experimental arv agents available through pre-approval access programs) * known ≥grade 3 of any of the following laboratory tests at screening or within 30 days prior to baseline visit: neutrophil count, hemoglobin, platelets, ast, alt, and creatinine, lipase; * total bilirubin ≥grade 3, unless all of the following are true: current regimen includes atazanavir; alt/ast \< 2.5 x uln; no symptoms other than jaundice or icterus. * other laboratory values ≥grade 3, must be reviewed by pfizer.

Keywords: open label pharmacokinetic safety and efficacy in hiv-1 infected pediatrics
tigecycline for treatment of rapidly growing mycobacteria

Conditions: Mycobacterium Abscessus Lung Disease; Rapidly Growing Mycobacterial Lung Disease

Summary: to determine the safety, tolerance, and efficacy of tigecycline when given daily to patients with rapidly growing mycobacterial disease (especially m.abscessus).

to assess the safety and efficacy of tigecycline in the treatment of drug resistant rapidly growing mycobacterial disease especially m. abscessus

Eligibility criteria:
inclusion criteria: * positive cultures for rapidly growing mycobacteria * patients who have drug resistant isolates or are intolerant of macrolides or have serious infections unresponsive to currently available drugs * adults and children 10 years of age and older * pretreatment isolate of m. avium complex available for mic determination * available for followup appointments exclusion criteria: * history of tetracycline allergy * if a menstruating female, not pregnant and on adequate birth control
study to assess the long-term safety, tolerability, and efficacy of amg 827 in subjects with psoriasis

Conditions: Psoriasis

Summary: this study is an open-label extension of study 20090062 to evaluate extended subcutaneous dosing.

this study is an open-label extension of study 20090062 to evaluate extended subcutaneous dosing of amg 827 for up to 362 weeks.

Eligibility criteria:
inclusion criteria: * subject was randomized into study 20090062 and completed the week 16 evaluation. exclusion criteria: * subject had any serious adverse event (sae) reported during study 20090062 that was considered possibly related to ip. * subject experienced an adverse event in study 20090062 that, in the opinion of the investigator, could cause extension of treatment to be detrimental to the subject.

Keywords: psoriasis
a study of 1592u89 in hiv-infected adults

Conditions: HIV Infections

Summary: the purpose of this study is to see if it is safe and effective to give 1592u89 to hiv-positive adults. this study also examines the influence previous anti-hiv treatment has on the effectiveness of 1592u89.

patients receive open-label 1592u89 administered orally in combination with at least one other antiretroviral agent that the patient has not previously received.

Eligibility criteria:
inclusion criteria concurrent medication: allowed: erythropoietin, g-csf and gm-csf. patients must have: * cd4+ cell count \< 100 cells/mm3. * hiv-1 rna \> 30,000 copies/ml. * signed, informed consent from parent or legal guardian for patient under 18 years of age. exclusion criteria co-existing condition: patients with the following conditions or symptoms are excluded: * renal failure requiring dialysis. * hepatic failure evident by grade 3/4 hyperbilirubinemia and ast 5 times the upper limit of normal. * documented hypersensitivity to 1592u89. * serious medical conditions, such as diabetes, congestive heart failure, cardiomyopathy, or other cardiac dysfunction, that would compromise the safety of the patient. * participation in or ability to participate in an enrolling study of 1592u89. required: at least 2 nucleoside reverse transcriptase inhibitors (nrti) and one protease inhibitor (or intolerance to one protease inhibitor and one nrti due to trying at least 2 different regimens with at least one protease inhibitor). alcohol or illicit drug use that may interfere with the patient's compliance.

Keywords: hiv-1 administration, oral cd4 lymphocyte count rna, viral reverse transcriptase inhibitors anti-hiv agents viral load abacavir
clinical situations leading to the prescription of neuroleptics by general practitioner in the elderly. practice survey

Conditions: Behavior Disorders; Neuroleptic

Summary: behavioral disorders of psychiatric or neurological origin in the elderly are an emerging public health problem. its management can include a prescription of psychotropic drugs (anxiolytics, hypnotics, neuroleptics, antidepressants for the most part). many studies highlight the misuse of psychotropic drugs in this specific and vulnerable population, as well as the need for targeted actions. as for neuroleptics, there is a deleterious over-prescription in the so-called productive behavioral disorders (cries, agitation, aggressiveness, ambulation), in particular in the patient with alzheimer's disease (80% of patients) or related. the same applies to behavioral disorders in an acute episode of confusion, which also constitute a situation for the prescribing of psychotropic drugs in the elderly. the frailty of the elderly associated with neuroleptics is the cause of a significant iatrogenic (falls, confusions, excessive sedation, etc.), iatrogeny is largely avoidable. there is little data on the representation of behavioral disorders in the elderly, whereas the recognition and management of behavioral disorders are functions of the tolerance of the entourage and the training of the caregivers. significant data exist in the literature about diagnosis, risk factors, factors favoring or triggering behavioral disorders and somatic pathologies to be sought urgently. the available recommendations on the drug treatment of behavioral disorders are complex and inappropriate in light of new data, including the dangerousness of psychotropic drugs. the deleterious effect of long-term drug treatments is proved. there is no validated drug strategy, especially in acute confusions of the elderly. one study showed that there was a change in the type of neuroleptic prescribed between 2003 and 2010. half of the general practitioners studied during this period switched from a first-generation neuroleptic to a second-generation neuroleptic. nevertheless, the type of molecule chosen remains at the discretion of the treating physician or even required a psychiatric opinion or a passage in the emergencies. in the case where the practitioner initiates a prescription in office, in the home or in ehpad, certain situations require the choice of a neuroleptic with or without pre-therapeutic assessment.


Eligibility criteria:
inclusion criteria: * general practitioner of the somme, * having patients aged 75 and over exclusion criteria: * general practitioner with a complementary specialty related to psychiatry, neurology or geriatrics (capacity, university degree or inter-university)
safety study of gnbac1 in multiple sclerosis patients

Conditions: Multiple Sclerosis

Summary: the purpose of this study is to assess the safety and tolerability of single ascending doses, as well as of repeated administrations of gnbac1 in ms patients. scientific research has shown that the expression of genes of a virus which is integrated in the human genetic material, the multiple sclerosis associated retrovirus (msrv) could play a critical role in the causation of multiple sclerosis. gnbac1 is an experimental medication, which neutralizes (i.e. inactivates) a protein of msrv that might contribute to the development or deterioration of multiple sclerosis.


Eligibility criteria:
inclusion criteria: * male or female patients (if female, neither pregnant nor breast-feeding, should be post-menopausal or surgically sterile, or should use two highly effective method of contraception such as oral contraception plus mechanical barrier); male subjects with partners of childbearing potential have to use adequate contraception during the study. contraception methods should be followed during the study and up to 3 months after the last study drug administration. female subjects who are women of childbearing potential (wocbp) will have to be tested negative with a pregnancy test (serum or urine) at screening and day 1 and before each repeated administrations of gnbac1. * between 18 and 65 years of age; * patients with primary progressive ms (ppms) according to the revised mcdonald criteria 2010 or patients with secondary progressive ms (spms) or patients with relapsing-remitting ms(rrms)according to the revised mcdonald criteria 2010 who cannot be treated with available treatments for ms due to intolerance, non response or refusal of treatment; * score ≤ 6.5 on the expanded disability status scale (edss); * body weight between 40 and 100kg. exclusion criteria: * positive serology for viral hepatitis and hiv; * disease other than ms that could better explain his/her signs and symptoms; * previously treated with cladribine, lymphoid irradiation or depleting antibodies; * usage in the last 3 months of interferon beta or glatiramer acetate; * any usage in the last 6 months of mitoxantrone, cytotoxic immunosuppressive therapy, natalizumab, fingolimod or immunoglobulin; * usage within 30 days prior to baseline of oral or systemic corticosteroids or acth; * inadequate liver function; * severe renal impairment; * severe psychiatric disorder; * known inability to undergo an mri scan; * having participated in another clinical study within 6 months prior to study baseline except for patients who have participated or who are currently participating in an interventional study without any study drug intake. * pregnancy or breastfeeding * female subjects considering becoming pregnant during the study

Keywords: relapsing forms of multiple sclerosis progressive forms of multiple sclerosis gnbac1 monoclonal antibody multiple sclerosis associated retrovirus (msrv) temelimab